Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
725 participants
OBSERVATIONAL
2006-05-31
2012-09-30
Brief Summary
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2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.
3. The study population is female subjects \> 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.
4. The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure.
5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Phase I (IntePro, US only)
AMS Apogee™ with IntePro(Began May 2006 - Closed)
AMS Apogee™ with IntePro
Mesh implant for posterior wall pelvic organ prolapse
Phase I (InteXen LP, US only)
AMS Apogee™ with InteXen LP (Began May 2006 - Closed)
AMS Apogee™ with Intexen LP
Graft implant for posterior wall pelvic organ prolapse
Phase II (France only)
AMS Perigee™ with IntePro (Began February 2007 - Closed)
AMS Perigee™ with IntePro
Mesh implant for anterior wall pelvic organ prolapse
Phase III/IV (Perigee IntePro Lite, US only)
AMS Perigee™ with IntePro Lite (Began April 2007 - Closed)
AMS Perigee™ with IntePro Lite
Mesh implant for anterior wall pelvic organ prolapse
Phase III/IV (Apogee IntePro Lite, US only)
AMS Apogee™ with IntePro Lite (Began April 2007 - Closed)
AMS Apogee™ with IntePro Lite
Mesh implant for posterior wall pelvic organ prolapse
Phase V (Elevate Posterior IntePro Lite, US & EU)
AMS Elevate™ Apical \& Posteiror with IntePro Lite (Began April 2008 - Closed)
AMS Elevate™ Apical & Posteiror with IntePro Lite
Mesh implant for apical and posterior wall pelvic organ prolapse
Phase V (Elevate Posterior InteXen, US only)
AMS Elevate™ Apical \& Posteiror with IntXen LP (Began April 2008 - Closed)
AMS Elevate™ Apical & Posteiror with IntXen LP
Graft implant for apical and posterior wall pelvic organ prolapse
Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only)
AMS Elevate™ Anterior \& Apical with IntePro Lite (Generation 1, For Study Use Only, Began October 2008 - Closed)
AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)
Mesh implant for anteiror and apical wall pelvic organ prolapse
Phase VII (Elevate Anterior Gen 2, US & EU)
AMS Elevate™ Anterior \& Apical with IntePro Lite (Generation 2, Began April 2009 - Closed)
AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)
Mesh implant for anteiror and apical wall pelvic organ prolapse
Interventions
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AMS Apogee™ with IntePro
Mesh implant for posterior wall pelvic organ prolapse
AMS Apogee™ with Intexen LP
Graft implant for posterior wall pelvic organ prolapse
AMS Perigee™ with IntePro
Mesh implant for anterior wall pelvic organ prolapse
AMS Perigee™ with IntePro Lite
Mesh implant for anterior wall pelvic organ prolapse
AMS Apogee™ with IntePro Lite
Mesh implant for posterior wall pelvic organ prolapse
AMS Elevate™ Apical & Posteiror with IntePro Lite
Mesh implant for apical and posterior wall pelvic organ prolapse
AMS Elevate™ Apical & Posteiror with IntXen LP
Graft implant for apical and posterior wall pelvic organ prolapse
AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)
Mesh implant for anteiror and apical wall pelvic organ prolapse
AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)
Mesh implant for anteiror and apical wall pelvic organ prolapse
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed.
* Subject has active or latent systemic infection or signs of tissue necrosis.
* Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis.
* Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered.
* Subject has had radiation therapy to the pelvic area.
* Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months.
* Subject has a known hypersensitivity to the graft material(s).
* Subject has uncontrolled diabetes.
* Subject is on any medication which could result in compromised immune response, such as immune modulators.
* Subject was involved in any other research trial \< 30 days of enrollment into this study.
* Subject has undergone previous pelvic surgery \< 6 months prior to enrollment in this study.
* Subject is unwilling or unable to give valid informed consent.
* Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits.
* Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).
21 Years
FEMALE
No
Sponsors
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ASTORA Women's Health
INDUSTRY
Responsible Party
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Principal Investigators
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James C. Lukban, DO
Role: PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School
Locations
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Kaiser Permanente - Dept. of Obstetrics & Gynecology
Downey, California, United States
Institute for Women's Health & Body
Wellington, Florida, United States
Atlanta Medical Research Institute
Alpharetta, Georgia, United States
Rosemark Womencare Specialists
Idaho Falls, Idaho, United States
Fore River Urology
Portland, Maine, United States
Maine Medical Partners
Portland, Maine, United States
Female Pelvic Health
Whitinsville, Massachusetts, United States
Female Pelvic Medicine and Urogynecology Inst. of Michigan
Grand Rapids, Michigan, United States
Michigan Medical P.C.
Grand Rapids, Michigan, United States
Women's Health Care Specialists, PC
Paw Paw, Michigan, United States
Metro Urology
Plymouth, Minnesota, United States
Piedmont Urology Associates
Gastonia, North Carolina, United States
Huey & Weprin Obstetrics & Gynecology
Englewood, Ohio, United States
South Carolina OB/GYN
Columbia, South Carolina, United States
University of Tennessee - Dept of Obstetrics & Gynecology
Memphis, Tennessee, United States
Texas Tech University Health Science Center - OB/GYN Department
El Paso, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
UZ Leuven Dept of Urology
Leuven, , Belgium
CMC Beau Soleil
Montpellier, , France
Service urologie de Paris l'Hôpital Tenon
Paris, , France
Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest
Paris, , France
CHU de Rouen - Pavillon Derocque - Rez de Chaussée
Rouen, , France
Clinique Adassa
Strasbourg, , France
Dr. Rainer Lange
Alzey, , Germany
Beckenbodenzentrum Munich
Munich, , Germany
University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics
Amsterdam, , Netherlands
Hospitalet General de l'Hospitalet
Barcelona, , Spain
University Hospital of Leicester NHS Trust
Leicester, , United Kingdom
Countries
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References
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Lukban JC, Roovers JP, Vandrie DM, Erickson T, Zylstra S, Patel MP, Moore RD. Single-incision apical and posterior mesh repair: 1-year prospective outcomes. Int Urogynecol J. 2012 Oct;23(10):1413-9. doi: 10.1007/s00192-012-1692-4. Epub 2012 Mar 15.
Lukban JC, Beyer RD, Moore RD. Incidence of extrusion following type I polypropylene mesh "kit" repairs in the correction of pelvic organ prolapse. Obstet Gynecol Int. 2012;2012:354897. doi: 10.1155/2012/354897. Epub 2011 Dec 10.
Moore RD, Lukban JC. Comparison of vaginal mesh extrusion rates between a lightweight type I polypropylene mesh versus heavier mesh in the treatment of pelvic organ prolapse. Int Urogynecol J. 2012 Oct;23(10):1379-86. doi: 10.1007/s00192-012-1744-9. Epub 2012 May 10.
Liedl B, Barba M, Wenk M. [Pelvic floor reconstruction-update 2024: prolapse-associated symptoms and their treatment]. Urologie. 2024 Jan;63(1):43-50. doi: 10.1007/s00120-023-02247-6. Epub 2023 Dec 28. German.
Himmler M, Gottl K, Witczak M, Yassouridis A, Gold DM, Liedl B. The impact of transvaginal, mesh-augmented level one apical repair on anorectal dysfunction due to pelvic organ prolapse. Int Urogynecol J. 2022 Nov;33(11):3261-3273. doi: 10.1007/s00192-022-05151-3. Epub 2022 Mar 28.
Related Links
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AMS website
Other Identifiers
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1004
Identifier Type: -
Identifier Source: org_study_id
NCT00793039
Identifier Type: -
Identifier Source: nct_alias